Section VIII Carve-Outs Remain Viable in the Wake of GSK v. Teva

Last week, Judge Andrews from the District of Delaware granted Defendant Hikma’s motion to dismiss Plaintiff Amarin’s induced infringement claims related to the drug Vascepa®. Amarin Pharma, Inc. v. Hikma Pharm. USA Inc. Amarin sells Vascepa® for two indications: severe hypertriglyceridemia (the “SH indication”) and cardiovascular risk reduction (the “CV indication”). Hikma received FDA approval to sell a generic version of Vascepa® for the SH indication only based on a “section viii carve-out” of the CV indication. Nevertheless, Amarin filed a complaint that asserted patents directed to the CV indication alone.

Hikma moved to dismiss, arguing that Amarin had not adequately plead that Hikma induced infringement. Amarin responded that despite Hikma’s carve out it still induced doctors to prescribe the product for the CV indication. Amarin argued that under GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021) Hikma’s label was “not skinny enough” and that other public statements by Hikma induced infringement.  Judge Andrews rejected Amarin’s arguments.

With regard to Hikma’s label, Amarin first argued the label induced infringement because it provided a warning regarding side effects for patients with CV. Judge Andrews concluded that the language of the warning about potential side effects for patients with CV was “hardly instruction or encouragement” to prescribe the product to those patients.  Amarin then argued that Hikma’s label did not teach doctors not to use the product to treat CV.  Judge Andrews held that this silence did not induce infringement.

Amarin also argued that Hikma’s advertisements induced infringement.  Amarin first pointed to Hikma’s statements that its product was the “generic equivalent to Vascepa®”.  Judge Andrews held that these statements may be relevant to intent to induce but did not support actual inducement.  Amarin also argued that Hikma’s advertisement of the product in the therapeutic category “hyperglyceridemia” induced infringement.  Judge Andrews rejected this argument because the category of hyperglyceridemia included non-infringing uses and therefore the mere statement that Hikma’s drug fell within that category did not prove inducement.

This case indicates that the Federal Circuit’s GSK  decision does not kill the viability of Section VIII carve outs. It also provides a good illustration of the types of facts a Court will examine when determining whether a generic company induced infringement despite carving out the relevant indication. Generic companies should continue to use Section VIII carve outs strategically and should control their public statements to ensure that they avoid inducing infringement despite carving out a particular indication.